CentriMag Circulatory Support System
FDA premarket approval P170038 · decided 2019-12-06
Approval details
- PMA number
- P170038
- Trade name
- CentriMag Circulatory Support System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abbott
- Date received
- 2017-11-24
- Decision date
- 2019-12-06
- Days to decision
- 742 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for temporary circulatory support for up to 30 days for one or both sides of the heart to treat postcardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
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